GAMP®5, 2nd Edition & Alignment with FDA's Draft Guidance for Computer Software Assurance(CSA)

Carolyn Troiano Instructor:
Carolyn Troiano 
Thursday, September 5, 2024
10:00 AM PDT | 01:00 PM EDT
90 Minutes
Webinar ID: 502308

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$299 Corporate Live
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$399 Corporate Recorded
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We'll cover in detail the differences between GAMP®5, 2nd Edition, issued in July 2022 and the original version of GAMP®5.

The 2nd Edition aligns very well with Computer Software Assurance (CSA), a draft guidance from FDA issued in September 2022. We'll cover the pros and cons of CSV and CSA, and the importance of including GAMP®5 best practices in the validation process.

A key element is a risk-based, product quality and patient-centric approach to Computer System Assurance (CSA), issued as a draft guidance in September 2022 vs. the traditional Computer System Validation (CSV) waterfall approach. CSA encourages critical thinking based on product and process knowledge and quality risk management over prescriptive documentation driven approaches. It also provides the ability to use automated testing to improve validation efficiency and effectiveness.

This is where FDA determined that "WHAT" is required can be done in different ways (the "HOW") and does not have to be according to the "checklist" mindset of most CSV work, where you crank out documents without specifically addressing the risk of potential failure of each requirement.

GAMP®5 supports the use of incremental, iterative, and evolutionary approaches including agile and automated testing for development of custom applications. Keys to success include a robust Quality Management System (QMS) and well trained and highly disciplined teams following well-defined processes supported by tools and automation.

This webinar will include a comparison of the agile and waterfall methodologies, along with the pros and cons of each. There may not be one size that fits all, and so it is important to understand what needs to be considered when making such a determination.

Why should you Attend: The attendee will learn about FDA's approach to modernizing technology, and how that will benefit both the Agency and industry. You will learn the differences between GAMP®5, 2nd Edition and the original GAMP®5 version, and how the 2nd Edition aligns with many of the principles of Computer Software Assurance (CSA). These can be leveraged to ensure compliance with FDA requirements for validation, 21 CFR Part 11 (electronic records & electronic signatures), and data integrity requirements.

We'll cover the trend toward using non-linear types of software development, testing, and release, such as agile. We will discuss ways to modernize the System Development Life Cycle (SDLC) approach to using automated testing tools that will result in a continuous validation of software products. This approach is amenable to the agile software development methodology, which can be adapted for use in validation. We'll discuss the pros and cons of each approach, and industry best practices for success.

We'll cover Computer-Off-the-Shelf (COTS) software & Software-as-a-Service (SaaS).

You'll learn how to select an optimal solution and ensure that whatever that might be, you can build a contract and Service Level Agreement (SLA) that best suits your environment and needs.

Areas Covered in the Session:

  • Learn how to identify "GxP" Systems
  • Learn about FDA's current thinking about technology and software development, and how this will impact industry
  • Learn about GAMP®5, 2nd Edition, the differences from the original version of GAMP®5, and how it aligns more closely with the CSA approach to validation
  • Discuss the current state of Computer System Validation (CSV) approach based on FDA requirements and the Computer Software Assurance (CSA) approach, based on the draft guidance from FDA in September 2022
  • Learn about the System Development Life Cycle (SDLC) approach to validation and how this can be modernized through a more agile approach, including automated testing for continuous validation
  • We will discuss cloud computing, Computer Off-the-Shelf (COTS) software validation, and Software-as-a-Service (SaaS)
  • Understand how to maintain a system in a validated state through the system's entire life cycle in a more cost-effective manner, applying an agile continuous validation approach
  • Learn how to assure the integrity of data and compliance with 21 CFR Part 11 to support GxP work, in the face of advances in new technology and the challenges they pose
  • Learn about the policies and procedures needed to support your validation process and ongoing maintenance of your systems in a validated state
  • Finally, understand the industry best practices that will enable you to optimize your approach to validation and compliance, based on risk assessment, to ensure data integrity is maintained throughout the entire data life cycle
  • Q&A

Who Will Benefit:
  • Information Technology (IT) Analysts
  • IT Developers
  • IT Support Staff
  • IT Security Staff
  • QC/QA Managers and Analysts
  • Production Managers and Supervisors
  • Supply Chain Managers and Supervisors
  • Clinical Data Managers and Scientists
  • Compliance Managers and Auditors
  • Lab Managers and Analysts
  • Computer System Validation Specialists
  • GMP, GLP, GCP Training Specialists
  • Business Stakeholders using Computer Systems regulated by FDA
  • Regulatory Affairs Personnel
  • Consultants in the Life Sciences and Tobacco Industries
  • Interns working at the companies listed above
  • College students attending schools and studying computer system validation, regulatory affairs/matters (related to FDA) or any other discipline that involves adherence to FDA regulatory requirements

Speaker Profile
Carolyn (McKillop) Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs. Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area.

During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA's electronic record/electronic signature regulation.

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